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Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring

NCT ID: NCT01053104

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-04-30

Brief Summary

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To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.

Detailed Description

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Patients with metastatic colorectal or breast cancer will be recruited.

* Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles
* Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles.

All patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. Thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. Patient experience in the trial will also be evaluated during their participation in the trial.

Patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.

Conditions

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Metastatic Colorectal Cancer Metastatic Breast Cancer

Keywords

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Colorectal cancer Breast cancer Capecitabine Docetaxel Mobile phone Toxicity Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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capecitabine 2000mg/m2 (Colorectal)

capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)

No interventions assigned to this group

capecitabine 2500mg/m2 (Colorectal)

capecitabine 2500mg/m2 d 1-14, q 3 weekly

No interventions assigned to this group

capecitabine 2000mg/m2 (Breast)

capecitabine 2000mg/m2d 1-14, q 3 weekly

No interventions assigned to this group

docetaxel 75mg/m2 (Breast)

capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens

For metastatic colorectal cancer:

* capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
* capecitabine 2500mg/m2 d 1-14, q 3 weekly

For metastatic breast cancer:

* capecitabine 2000mg/m2d 1-14, q 3 weekly
* capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
* Age \> 18 years
* Fit to start at full (100%) starting dose of all drugs
* Able and willing to use mobile phone
* Reasonable renal, liver and bone marrow function
* Absolute neutrophil count (ANC) \>1.5 x 109/L
* Platelet count \> 100 x 109/L
* Total bilirubin \<1.5 ULN
* ALT, AST \< 2.5 x ULN
* Alkaline phosphatase \< 2.5 x ULN
* No obvious contra indications to capecitabine or oxaliplatin or docetaxel
* Patients must also be able to read, write and understand English.

Exclusion Criteria

* Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials
* Moderate or severe renal impairment \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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oxBRC

UNKNOWN

Sponsor Role collaborator

Vodafone UK Foundation

UNKNOWN

Sponsor Role collaborator

Centre for Statistics in Medicine

OTHER

Sponsor Role collaborator

Oncology Clinical Trials Office (OCTO, Oxford)

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford Cancer Centre, Churchill Hospital

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.octo-oxford.org.uk/

Oncology Clinical Trials Office (OCTO)

Other Identifiers

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OCTO/Oxford

Identifier Type: OTHER

Identifier Source: secondary_id

Mobile Datacap

Identifier Type: -

Identifier Source: org_study_id